Government-Owned Inventions; Availability for Licensing, 34392-34393 [2012-14038]
Download as PDF
<![CDATA[
34392
Federal Register / Vol. 77, No. 112 / Monday, June 11, 2012 / Notices
Frequency of Response: Annually or
biennially. Affected Public: Individuals
or households; businesses or other for
profit; state or local governments;
Federal agencies; non-profit institutions;
small businesses or organizations. Type
of Respondents: Organizations, medical
researchers, physicians and other health
Estimated
number of respondents
Types of respondents
Estimated
number of responses per
respondent
Average burden hours per
response
Estimated total
annual burden
hours requested
15,000
1
.150
2,250
srobinson on DSK4SPTVN1PROD with NOTICES
Researchers, Physicians, Other Health Care Providers, Librarians, Students, General Public ...................................................................................
The annualized cost to respondents for
each year of the generic clearance is
estimated to be $20,670. There are no
Capital Costs, Operating Costs, and/or
Maintenance Costs to report.
Request For Comments: Written
comments and/or suggestions from the
public and affected agencies should
address one or more of the following
points: (1) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) Evaluate the
accuracy of the agency’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and (4) Minimize the burden
of the collection of information on those
who are to respond, including the use
of appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact: David
Sharlip, National Library of Medicine,
Building 38A, Room B2N12, 8600
Rockville Pike, Bethesda, MD 20894, or
call non-toll free number 301–402–9680
or email your request to
sharlipd@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
VerDate Mar<15>2010
20:21 Jun 08, 2012
Jkt 226001
care providers, librarians, students, and
the general public. The annual reporting
burden is as follows:
Dated: June 5, 2012.
David H. Sharlip,
NLM Project Clearance Liaison, National
Library of Medicine, National Institutes of
Health.
[FR Doc. 2012–14140 Filed 6–8–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
FOR FURTHER INFORMATION: Licensing
information and copies of the U.S.
patent applications listed below may be
obtained by writing to the indicated
licensing contact at the Office of
Technology Transfer, National Institutes
of Health, 6011 Executive Boulevard,
Suite 325, Rockville, Maryland 20852–
3804; telephone: 301–496–7057; fax:
301–402–0220. A signed Confidential
Disclosure Agreement will be required
to receive copies of the patent
applications.
SUMMARY:
Treatment of Viral Infection by
Blocking Interleukin-21
Description of Technology: Blocking
interleukin (IL-21) may be an effective
method to treat or prevent various viral
infections. In the course of an immune
response to a virus, IL-21, produced
primarily by CD4∂ T cells, can inhibit
or stimulate (regulate), immune cell
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
function (B cells, T cells, natural killer
cells, dendritic cells). IL-21 regulation
may be either protective or pathological;
autoimmune disease pathology has been
associated with IL-21 promoted
inflammation (in: Type 1 diabetes,
lupus, and multiple sclerosis). This
technology describes methods of
blocking IL-21 that may reduce
damaging inflammatory responses
during certain viral infections.
Specifically, the absence of IL-21 during
respiratory viral infection such as
pneumonia virus infection actually
prevents some of the pathogenic effects
that may be promoted by IL-21. Methods
for controlling IL-21 signaling may be
used to treat to prevent many
pathological effects of pneumonia
viruses, and other viral infections.
Potential Commercial Applications:
Prevention and treatment of many
pathological effects of viral infections,
including pneumonia.
Competitive Advantages: New method
for treating viral infection pathology.
Development Stage:
• Early-stage.
• Pre-clinical.
• In vivo data available (animal).
Inventors: Warren J. Leonard and
Rosanne Spolski (NHLBI).
Publication: Spolski R, et al. IL-21
promotes the pathologic immune
response to pneumovirus infection. J
Immunol. 2012 Feb 15;188(4):1924–32.
[PMID 22238461].
Intellectual Property: HHS Reference
No. E–017–2012/0—U.S. Provisional
Application No. 61/579,801 filed 23 Dec
2011.
Licensing Contact: Tedd Fenn; 301–
435–5031; Tedd.Fenn.nih.gov.
Collaborative Research Opportunity:
The NHLBI is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize treatment of viral
infection by blocking Interleukin-21 (E–
017–2012). For collaboration
opportunities, please contact Vincent
Kolesnitchenko, Ph.D. at
kolesniv@nhlbi.nih.gov.
E:\FR\FM\11JNN1.SGM
11JNN1
Federal Register / Vol. 77, No. 112 / Monday, June 11, 2012 / Notices
srobinson on DSK4SPTVN1PROD with NOTICES
Transgenic ZP2 Mouse Model Produces
Eggs That Bind to Human Sperm
Protein
Description of Technology: Fertilizing
sperm bind to an extracellular coat
surrounding mammalian eggs called
zona pellucida. Depending on the
species, the zona pellucida is composed
of ZP1, ZP2, ZP3, and/or ZP4 proteins.
Recent studies show that sperm
successfully adhere to the zona
pellucida surface when ZP2 is intact. In
contrast, when ZP2 has been
proteolytically cleaved, sperm binding
is disrupted.
To further study the effect of ZP2
cleavage in sperm-egg recognition,
researchers at NIDDK have developed a
transgenic mouse expressing human
ZP2. Prior attempts using ZP2 knockout
mice were unsuccessful because the
produced eggs were not fertile in vivo.
Transgenic ZP2 mice produced
humanized zonae pellucida, and
produced fertile eggs to which human
sperm successfully and specifically
bound. This mouse model contradicts
previous notions that production of
human transgenic ZP2 would adversely
change the specificity of sperm binding.
Potential Commercial Applications:
• Transgenic eggs can be used in
diagnostic functional assays to assess
human sperm viability for reproductive
technologies.
• Diagnostic assay can be extended to
determine presence of male infertility in
a variety of mammals, including pets,
farm livestock, and zoological
mammals.
Competitive Advantages:
• This ZP2 mice model produces eggs
containing transgenic mammalian zona
pellucida, which can successfully and
specifically be fertilized with the
corresponding mammalian sperm.
• Use in human infertility studies
spares the use of a human egg for
binding studies.
Development Stage:
• Prototype.
• Early-stage.
• In vitro data available.
• In vivo data available (animal).
Inventors: Tracy L. Rankin, Jenell S.
Coleman, Olga Epifano, Tanya
Hoodbhoy, Scott Turner, Jurrien Dean
(all of NIDDK).
Publications:
1. Rankin TL, et al. Fertility and taxonspecific sperm binding persist after
replacement of mouse sperm
receptors with human homologs.
Dev Cell. 2003 Jul;5(1):33–43.
[PMID 12852850].
2. Gahlay G, et al. Gamete recognition in
mice depends on the cleavage status
of an egg’s zona pellucida protein.
VerDate Mar<15>2010
20:21 Jun 08, 2012
Jkt 226001
Science. 2010 Jul 9;329(5988):216–
9. [PMID 20616279].
Intellectual Property: HHS Reference
No. E–288–2011/0—Research Tool.
Patent protection is not being pursued
for this technology.
Related Technology: HHS Reference
No. E–162–2011/0—Research Tool.
Patent protection is not being pursued
for this technology.
Licensing Contact: Lauren NguyenAntczak, Ph.D., J.D.; 301–435–4074;
Lauren.Nguyen-antczak@nih.gov.
Englerin A: A Novel Renal Cancer
Therapeutic Isolated From an African
Plant
Description of Technology: Renal cell
cancer of the kidney accounts for 13
thousand deaths per year, largely due to
the ineffective treatment methods
available. The current standard of care
is limited to surgical resection of the
diseased tissue and to date
chemotherapy/radiation intervention
has been of limited effectiveness.
Researchers at the NIH have isolated
a series of novel natural compounds
from the African plant Phyllanthus
engleri that display potent anti-cancer
properties, particularly in renal cancer
cell lines. Englerin A displays renal
cancer cell line growth inhibition in
vitro and efficacy against renal and
prostate cancer cell lines in vivo. The
compound can be efficiently extracted
from the plant, and recent work has
described methods for the synthesis of
Englerin A and novel analogs.
Further preclinical studies have
yielded an optimized formulation for
parenteral drug administration, the
establishment of a method for
measuring bioavailability, and modeling
studies suggestive that Englerin A
should be orally bioavailable.
Potential Commercial Applications:
The new chemical entities can be
potential cancer therapeutics, especially
for renal cancer.
Competitive Advantages:
• Isolated compounds are specifically
toxic to renal cancer cells, a disease
with limited current chemotherapeutic
options.
• Compounds are effective in vivo
and have potential applications to other
disease states.
• There is reasonable yield and
recovery of the compounds from the
natural product extracts.
• Recent work has identified efficient
routes for synthesis of Englerin A.
Development Status:
• Pre-clinical.
• In vitro data available.
• In vivo data available (animal).
Inventors: John A. Beutler et al. (NCI).
Publications:
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
34393
1. Ratnayake R, et al. Englerin A, a
selective inhibitor of renal cancer
cell growth, from Phyllanthus
engleri. Org Lett. 2009 Jan
1;11(1):57–60. [PMID 19061394].
2. Li Z, et al. A brief synthesis of
(-)-englerin A. J Am Chem Soc. 2011
May 4;133(17):6553–6. [PMID
21476574].
3. Akee R, et al. Chlorinated englerins
with selective inhibition of renal
cancer cell growth. J Nat Prod. 2012
Mar 23;75(3):459–63. [PMID
22280462].
Intellectual Property: HHS Reference
No. E–064–2008/2—U.S. Patent
Application No. 12/811,245 filed 29 Jul
2010.
Related Technology: HHS Reference
No. E–042–2012/0—U.S. Provisional
Application No. 61/584,526 filed 09 Jan
2012, ‘‘Use of Englerin A for the
Treatment of Diabetes, Obesity and
Other Diseases.’’
Licensing Contact: Surekha Vathyam,
Ph.D.; 301–435–4076;
vathyams@mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute Molecular
Targets Development Program is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate, or
commercialize epoxy-guaiane cancer
inhibitors. Please contact John D.
Hewes, Ph.D. at 301–435–3121 or
hewesj@mail.nih.gov for more
information.
Dated: June 5, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2012–14038 Filed 6–8–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
E:\FR\FM\11JNN1.SGM
11JNN1
]]>Agencies
[Federal Register Volume 77, Number 112 (Monday, June 11, 2012)]
[Notices]
[Pages 34392-34393]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14038]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The inventions listed below are owned by an agency of the U.S.
Government and are available for licensing in the U.S. in accordance
with 35 U.S.C. 207 to achieve expeditious commercialization of results
of federally-funded research and development. Foreign patent
applications are filed on selected inventions to extend market coverage
for companies and may also be available for licensing.
FOR FURTHER INFORMATION: Licensing information and copies of the U.S.
patent applications listed below may be obtained by writing to the
indicated licensing contact at the Office of Technology Transfer,
National Institutes of Health, 6011 Executive Boulevard, Suite 325,
Rockville, Maryland 20852-3804; telephone: 301-496-7057; fax: 301-402-
0220. A signed Confidential Disclosure Agreement will be required to
receive copies of the patent applications.
Treatment of Viral Infection by Blocking Interleukin-21
Description of Technology: Blocking interleukin (IL-21) may be an
effective method to treat or prevent various viral infections. In the
course of an immune response to a virus, IL-21, produced primarily by
CD4+ T cells, can inhibit or stimulate (regulate), immune
cell function (B cells, T cells, natural killer cells, dendritic
cells). IL-21 regulation may be either protective or pathological;
autoimmune disease pathology has been associated with IL-21 promoted
inflammation (in: Type 1 diabetes, lupus, and multiple sclerosis). This
technology describes methods of blocking IL-21 that may reduce damaging
inflammatory responses during certain viral infections. Specifically,
the absence of IL-21 during respiratory viral infection such as
pneumonia virus infection actually prevents some of the pathogenic
effects that may be promoted by IL-21. Methods for controlling IL-21
signaling may be used to treat to prevent many pathological effects of
pneumonia viruses, and other viral infections.
Potential Commercial Applications: Prevention and treatment of many
pathological effects of viral infections, including pneumonia.
Competitive Advantages: New method for treating viral infection
pathology.
Development Stage:
Early-stage.
Pre-clinical.
In vivo data available (animal).
Inventors: Warren J. Leonard and Rosanne Spolski (NHLBI).
Publication: Spolski R, et al. IL-21 promotes the pathologic immune
response to pneumovirus infection. J Immunol. 2012 Feb 15;188(4):1924-
32. [PMID 22238461].
Intellectual Property: HHS Reference No. E-017-2012/0--U.S.
Provisional Application No. 61/579,801 filed 23 Dec 2011.
Licensing Contact: Tedd Fenn; 301-435-5031; Tedd.Fenn.nih.gov.
Collaborative Research Opportunity: The NHLBI is seeking statements
of capability or interest from parties interested in collaborative
research to further develop, evaluate or commercialize treatment of
viral infection by blocking Interleukin-21 (E-017-2012). For
collaboration opportunities, please contact Vincent Kolesnitchenko,
Ph.D. at kolesniv@nhlbi.nih.gov.
[[Page 34393]]
Transgenic ZP2 Mouse Model Produces Eggs That Bind to Human Sperm
Protein
Description of Technology: Fertilizing sperm bind to an
extracellular coat surrounding mammalian eggs called zona pellucida.
Depending on the species, the zona pellucida is composed of ZP1, ZP2,
ZP3, and/or ZP4 proteins. Recent studies show that sperm successfully
adhere to the zona pellucida surface when ZP2 is intact. In contrast,
when ZP2 has been proteolytically cleaved, sperm binding is disrupted.
To further study the effect of ZP2 cleavage in sperm-egg
recognition, researchers at NIDDK have developed a transgenic mouse
expressing human ZP2. Prior attempts using ZP2 knockout mice were
unsuccessful because the produced eggs were not fertile in vivo.
Transgenic ZP2 mice produced humanized zonae pellucida, and produced
fertile eggs to which human sperm successfully and specifically bound.
This mouse model contradicts previous notions that production of human
transgenic ZP2 would adversely change the specificity of sperm binding.
Potential Commercial Applications:
Transgenic eggs can be used in diagnostic functional
assays to assess human sperm viability for reproductive technologies.
Diagnostic assay can be extended to determine presence of
male infertility in a variety of mammals, including pets, farm
livestock, and zoological mammals.
Competitive Advantages:
This ZP2 mice model produces eggs containing transgenic
mammalian zona pellucida, which can successfully and specifically be
fertilized with the corresponding mammalian sperm.
Use in human infertility studies spares the use of a human
egg for binding studies.
Development Stage:
Prototype.
Early-stage.
In vitro data available.
In vivo data available (animal).
Inventors: Tracy L. Rankin, Jenell S. Coleman, Olga Epifano, Tanya
Hoodbhoy, Scott Turner, Jurrien Dean (all of NIDDK).
Publications:
1. Rankin TL, et al. Fertility and taxon-specific sperm binding persist
after replacement of mouse sperm receptors with human homologs. Dev
Cell. 2003 Jul;5(1):33-43. [PMID 12852850].
2. Gahlay G, et al. Gamete recognition in mice depends on the cleavage
status of an egg's zona pellucida protein. Science. 2010 Jul
9;329(5988):216-9. [PMID 20616279].
Intellectual Property: HHS Reference No. E-288-2011/0--Research
Tool. Patent protection is not being pursued for this technology.
Related Technology: HHS Reference No. E-162-2011/0--Research Tool.
Patent protection is not being pursued for this technology.
Licensing Contact: Lauren Nguyen-Antczak, Ph.D., J.D.; 301-435-
4074; Lauren.Nguyen-antczak@nih.gov.
Englerin A: A Novel Renal Cancer Therapeutic Isolated From an African
Plant
Description of Technology: Renal cell cancer of the kidney accounts
for 13 thousand deaths per year, largely due to the ineffective
treatment methods available. The current standard of care is limited to
surgical resection of the diseased tissue and to date chemotherapy/
radiation intervention has been of limited effectiveness.
Researchers at the NIH have isolated a series of novel natural
compounds from the African plant Phyllanthus engleri that display
potent anti-cancer properties, particularly in renal cancer cell lines.
Englerin A displays renal cancer cell line growth inhibition in vitro
and efficacy against renal and prostate cancer cell lines in vivo. The
compound can be efficiently extracted from the plant, and recent work
has described methods for the synthesis of Englerin A and novel
analogs.
Further preclinical studies have yielded an optimized formulation
for parenteral drug administration, the establishment of a method for
measuring bioavailability, and modeling studies suggestive that
Englerin A should be orally bioavailable.
Potential Commercial Applications: The new chemical entities can be
potential cancer therapeutics, especially for renal cancer.
Competitive Advantages:
Isolated compounds are specifically toxic to renal cancer
cells, a disease with limited current chemotherapeutic options.
Compounds are effective in vivo and have potential
applications to other disease states.
There is reasonable yield and recovery of the compounds
from the natural product extracts.
Recent work has identified efficient routes for synthesis
of Englerin A.
Development Status:
Pre-clinical.
In vitro data available.
In vivo data available (animal).
Inventors: John A. Beutler et al. (NCI).
Publications:
1. Ratnayake R, et al. Englerin A, a selective inhibitor of renal
cancer cell growth, from Phyllanthus engleri. Org Lett. 2009 Jan
1;11(1):57-60. [PMID 19061394].
2. Li Z, et al. A brief synthesis of (-)-englerin A. J Am Chem Soc.
2011 May 4;133(17):6553-6. [PMID 21476574].
3. Akee R, et al. Chlorinated englerins with selective inhibition of
renal cancer cell growth. J Nat Prod. 2012 Mar 23;75(3):459-63. [PMID
22280462].
Intellectual Property: HHS Reference No. E-064-2008/2--U.S. Patent
Application No. 12/811,245 filed 29 Jul 2010.
Related Technology: HHS Reference No. E-042-2012/0--U.S.
Provisional Application No. 61/584,526 filed 09 Jan 2012, ``Use of
Englerin A for the Treatment of Diabetes, Obesity and Other Diseases.''
Licensing Contact: Surekha Vathyam, Ph.D.; 301-435-4076;
vathyams@mail.nih.gov.
Collaborative Research Opportunity: The National Cancer Institute
Molecular Targets Development Program is seeking statements of
capability or interest from parties interested in collaborative
research to further develop, evaluate, or commercialize epoxy-guaiane
cancer inhibitors. Please contact John D. Hewes, Ph.D. at 301-435-3121
or hewesj@mail.nih.gov for more information.
Dated: June 5, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. 2012-14038 Filed 6-8-12; 8:45 am]
BILLING CODE 4140-01-P
